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American College of ACR Appropriateness Criteria® Imaging after and Reconstruction

Variant 1: Female. Breast . History of cancer, mastectomy side(s), no reconstruction.

Procedure Appropriateness Category Relative Radiation Level

US breast Usually Not Appropriate O Digital breast screening Usually Not Appropriate ☢☢ screening Usually Not Appropriate ☢☢ MRI breast without and with IV contrast Usually Not Appropriate O MRI breast without IV contrast Usually Not Appropriate O Sestamibi MBI Usually Not Appropriate ☢☢☢ FDG-PET breast dedicated Usually Not Appropriate ☢☢☢☢

Variant 2: Female. screening. History of cancer, autologous reconstruction side(s) with or without .

Procedure Appropriateness Category Relative Radiation Level

Digital breast tomosynthesis screening May Be Appropriate ☢☢ Mammography screening May Be Appropriate ☢☢ US breast Usually Not Appropriate O MRI breast without and with IV contrast Usually Not Appropriate O MRI breast without IV contrast Usually Not Appropriate O Sestamibi MBI Usually Not Appropriate ☢☢☢ FDG-PET breast dedicated Usually Not Appropriate ☢☢☢☢

Variant 3: Female. . History of cancer, nonautologous (implant) reconstruction side(s).

Procedure Appropriateness Category Relative Radiation Level

US breast Usually Not Appropriate O Digital breast tomosynthesis screening Usually Not Appropriate ☢☢ Mammography screening Usually Not Appropriate ☢☢ MRI breast without and with IV contrast Usually Not Appropriate O MRI breast without IV contrast Usually Not Appropriate O Sestamibi MBI Usually Not Appropriate ☢☢☢ FDG-PET breast dedicated Usually Not Appropriate ☢☢☢☢

ACR Appropriateness Criteria® 1 Imaging after Mastectomy and Variant 4: Female. Breast cancer screening. High-risk, bilateral prophylactic mastectomy, no reconstruction.

Procedure Appropriateness Category Relative Radiation Level

US breast Usually Not Appropriate O Digital breast tomosynthesis screening Usually Not Appropriate ☢☢ Mammography screening Usually Not Appropriate ☢☢ MRI breast without and with IV contrast Usually Not Appropriate O MRI breast without IV contrast Usually Not Appropriate O Sestamibi MBI Usually Not Appropriate ☢☢☢ FDG-PET breast dedicated Usually Not Appropriate ☢☢☢☢

Variant 5: Female. Breast cancer screening. High-risk, bilateral prophylactic mastectomy with autologous reconstructions.

Procedure Appropriateness Category Relative Radiation Level

US breast Usually Not Appropriate O Digital breast tomosynthesis screening Usually Not Appropriate ☢☢ Mammography screening Usually Not Appropriate ☢☢ MRI breast without and with IV contrast Usually Not Appropriate O MRI breast without IV contrast Usually Not Appropriate O Sestamibi MBI Usually Not Appropriate ☢☢☢ FDG-PET breast dedicated Usually Not Appropriate ☢☢☢☢

Variant 6: Female. Breast cancer screening. High-risk, bilateral prophylactic mastectomy with nonautologous (implant) reconstructions.

Procedure Appropriateness Category Relative Radiation Level

US breast Usually Not Appropriate O Digital breast tomosynthesis screening Usually Not Appropriate ☢☢ Mammography screening Usually Not Appropriate ☢☢ MRI breast without and with IV contrast Usually Not Appropriate O MRI breast without IV contrast Usually Not Appropriate O Sestamibi MBI Usually Not Appropriate ☢☢☢ FDG-PET breast dedicated Usually Not Appropriate ☢☢☢☢

ACR Appropriateness Criteria® 2 Imaging after Mastectomy and Breast Reconstruction Variant 7: Female. Palpable lump or clinically significant on the side of the mastectomy without reconstruction. Initial imaging.

Procedure Appropriateness Category Relative Radiation Level

US breast Usually Appropriate O Digital breast tomosynthesis diagnostic May Be Appropriate ☢☢ Mammography diagnostic May Be Appropriate ☢☢ MRI breast without and with IV contrast Usually Not Appropriate O MRI breast without IV contrast Usually Not Appropriate O Sestamibi MBI Usually Not Appropriate ☢☢☢ FDG-PET breast dedicated Usually Not Appropriate ☢☢☢☢

Variant 8: Female. Palpable lump or clinically significant pain on the side of the mastectomy with reconstruction (autologous or nonautologous). Initial imaging.

Procedure Appropriateness Category Relative Radiation Level

US breast Usually Appropriate O Digital breast tomosynthesis diagnostic May Be Appropriate ☢☢ Mammography diagnostic May Be Appropriate ☢☢ MRI breast without and with IV contrast Usually Not Appropriate O MRI breast without IV contrast Usually Not Appropriate O Sestamibi MBI Usually Not Appropriate ☢☢☢ FDG-PET breast dedicated Usually Not Appropriate ☢☢☢☢

ACR Appropriateness Criteria® 3 Imaging after Mastectomy and Breast Reconstruction IMAGING AFTER MASTECTOMY AND BREAST RECONSTRUCTION

Expert Panel on : Samantha L. Heller, MD, PhDa; Ana P. Lourenco, MDb; Bethany L. Niell, MD, PhDc; Nicolas Ajkay, MDd; Ann Brown, MDe; Elizabeth H. Dibble, MDf; Aarati D. Didwania, MDg; Maxine S. Jochelson, MDh; Katherine A. Klein, MDi; Tejas S. Mehta, MD, MPHj; Helen A. Pass, MDk; Ashley R. Stuckey, MDl; Mary E. Swain, MDm; Daymen S. Tuscano, MDn; Linda Moy, MD.o Summary of Literature Review Introduction/Background Mastectomy may be performed to treat breast cancer [1] with some authors reporting increasing rates of mastectomy relative to breast conservation in the United States [2-4]. Mastectomy may also be performed as a prophylactic approach in women with a high lifetime risk of developing breast cancer. Mastectomy techniques have changed over time with replaced by modified radical mastectomy and with options such as -sparing and -sparing procedures now available [5]. In addition, may be performed with or without reconstruction. Reconstruction approaches differ and may be autologous, involving a transfer of tissue (skin, subcutaneous fat, and muscle) from other parts of the body to the chest wall. Examples of autologous reconstruction include latissimus dorsi flaps, transverse rectus abdominis myocutaneous (TRAM) flaps, and variants such as deep inferior epigastric perforator flaps [1]. Reconstruction may also involve implants. Implant reconstruction may occur as a single procedure or as multistep procedures with initial use of an adjustable tissue expander allowing the mastectomy tissues to be stretched without compromising blood supply. Ultimately, a full-volume implant, which may be , silicone, or both, will be placed. Implant reconstruction often involves the placement of acellular matrix, which can increase risk of formation and occasionally is visible on imaging. Reconstructions with a combination of autologous and implant reconstruction may also be performed. Other techniques such as autologous fat grafting may be used to refine both implant and flap-based reconstruction [6]. Although most of the breast tissue is removed after mastectomy, recurrence may occur in residual tissue. The majority of recurrences in the reconstructed breast will be found in the skin and the subcutaneous tissues followed by recurrences deep to the pectoralis muscle [7]. Recurrence rates are reported to be approximately 1% to 2% annually for both mastectomy and mastectomy with reconstruction, and overall recurrence has been reported at between 2% to 15% and has been noted to vary based on the initial cancer type and stage as well as follow-up period of the study [5,7-13]. Clinical evaluation has been a mainstay of evaluation of the postmastectomy breast [4], and the appropriate surveillance imaging strategy for patients with a history of mastectomy with or without reconstruction is an evolving topic, with evidence predominantly drawn from small retrospective studies. Finally, women who have undergone mastectomy with or without reconstruction may present with symptomatic concerns, both in the immediate postoperative period and later. Sequalae of the , such as hematomas, infections, and most commonly in the early postoperative period, fat necrosis [7], may present as palpable findings. Recurrent disease may also present as a palpable lump [7,14]. Initial Imaging Definition Imaging at the beginning of the care episode for the medical condition defined by the variant. More than one procedure can be considered usually appropriate in the initial imaging evaluation when: • There are procedures that are equivalent alternatives (ie, only one procedure will be ordered to provide the clinical information to effectively manage the patient’s care) OR

aNew York University School of Medicine, New York, New York. bPanel Chair, Alpert Medical School of Brown University, Providence, Rhode Island. cPanel Vice-Chair, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida. dUniversity of Louisville School of Medicine, Louisville, Kentucky; Society of Surgical Oncology. eUniversity of Cincinnati, Cincinnati, Ohio. fAlpert Medical School of Brown University, Providence, Rhode Island. gNorthwestern University Feinberg School of Medicine, Chicago, Illinois; American College of Physicians. hMemorial Sloan Kettering Cancer Center, New York, New York. iUniversity of Michigan, Ann Arbor, Michigan. jBeth Israel Deaconess Medical Center, Boston, Massachusetts. kStamford Hospital, Stamford, Connecticut; American College of Surgeons. lWomen and Infants Hospital, Providence, Rhode Island; American College of Obstetricians and Gynecologists. mRadiology Associates of Tallahassee, Tallahassee, Florida. nCentral Oregon Radiology Associates, Bend, Oregon. oSpecialty Chair, NYU Clinical Cancer Center, New York, New York. The American College of Radiology seeks and encourages collaboration with other organizations on the development of the ACR Appropriateness Criteria through society representation on expert panels. Participation by representatives from collaborating societies on the expert panel does not necessarily imply individual or society endorsement of the final document. Reprint requests to: [email protected] ACR Appropriateness Criteria® 4 Imaging after Mastectomy and Breast Reconstruction • There are complementary procedures (ie, more than one procedure is ordered as a set or simultaneously in which each procedure provides unique clinical information to effectively manage the patient’s care). Discussion of Procedures by Variant Variant 1: Female. Breast cancer screening. History of cancer, mastectomy side(s), no reconstruction. Please note that this clinical scenario is focused on the appropriateness of imaging modalities for screening the side of the mastectomy. For screening of the contralateral native breast in the setting of a unilateral mastectomy, see the ACR Appropriateness Criteria® topic on “Breast Cancer Screening” [15]. FDG-PET Breast Dedicated There is no relevant literature to support the use of fluorine-18-2-fluoro-2-deoxy-D-glucose (FDG)-PET breast for screening in this clinical setting. Digital Breast Tomosynthesis Screening There is no relevant literature to support the use of digital breast tomosynthesis (DBT) for screening the postmastectomy side. However, annual screening with 2-D mammography or DBT is recommended for the contralateral native breast. DBT addresses some of the limitations encountered with standard 2-D mammographic views. In addition to planar images, DBT allows for creation and viewing of thin-section reconstructed images that may decrease the lesion-masking effect of overlapping normal tissue and reveal the true nature of potential false- positive findings. See the ACR Appropriateness Criteria® topic on “Breast Cancer Screening” [15] for further guidance. Mammography Screening Annual screening with 2-D mammography or DBT is recommended for the contralateral native breast. There is insufficient evidence to support screening with 2-D mammography of the postmastectomy side. Although one small retrospective study has shown a small increase in cancer detection with mammography in postmastectomy patients [16], another study has demonstrated no benefit [8]. MRI Breast Without IV Contrast There is no relevant literature to support the use of MRI breast without intravenous (IV) contrast for screening in this clinical setting. MRI Breast Without and With IV Contrast There is no relevant literature to support the use of MRI without and with IV contrast, specifically for screening the postmastectomy nonreconstructed breast. However, based on breast cancer risk, including factors such as age at cancer diagnosis, breast density, and family history, women with a personal history of cancer may undergo MRI for the contralateral native breast [17]. In this setting, the postmastectomy breast may be imaged and evaluated on MRI with potential for malignancy detection and characterization [18]. Sestamibi MBI There is no relevant literature to support the use of Tc-99m sestamibi molecular breast imaging (MBI) for screening in this clinical setting. US Breast There is insufficient evidence to support the use of (US) for screening in this setting. There is a paucity of evidence-based literature [16,18-20], with only a few small retrospective studies finding utility in screening with US in this setting. A subset of a retrospective study evaluated 67 women postmastectomy who had suspected recurrence and underwent US imaging; although some of these women were symptomatic, 7 recurrent impalpable were detected only on US in the cohort [16]. This study also found 3/61 cancers detected only on mammography and not on US. A study of 1,796 US examinations in 874 asymptomatic patients (median follow-up of 37 months) found 15 clinically occult recurrences detected with US in 15 patients (cancer detection rate of 1.7% per patient and 0.8% per examination) [19]. Lee et al [20] evaluated 1,180 consecutive screening USs of the mastectomy site and the ipsilateral axillary fossa in 468 asymptomatic women and found 10 malignancies with a similar cancer detection rate of 2.1% per patient and 0.8% per screening examination.

ACR Appropriateness Criteria® 5 Imaging after Mastectomy and Breast Reconstruction Variant 2: Female. Breast cancer screening. History of cancer, autologous reconstruction side(s) with or without implant. Please note that this clinical scenario is focused on the appropriateness of imaging modalities for screening the side of the mastectomy following reconstruction. For screening of the contralateral native breast in the setting of a unilateral mastectomy, see the ACR Appropriateness Criteria® topic on “Breast Cancer Screening” [15]. FDG-PET Breast Dedicated There is no relevant literature to support the use of FDG-PET breast for screening in this clinical setting. Digital Breast Tomosynthesis Screening Although insufficient studies have been performed to assess the utility of DBT in this setting, multiple investigations have demonstrated that DBT is helpful in the screening setting of the native breast, thus decreasing recall rates and increasing cancer detection rates compared to a conventional mammographic workup [21-26]. Mammography Screening Evidence is limited, but a few retrospective studies suggest a benefit to screening women with autologous reconstruction after mastectomy for cancer in the reconstruction side. Helvie et al [27] looked at 214 consecutive screening mammograms in 113 women with TRAM flap reconstructions, 106 (94%) of which were performed after mastectomy for cancer. The cancer detection rate was 0.9% per screen and 1.9% per patient (2/106, 95% confidence interval [CI]: 0.33%, 7.32%) and positive predictive value (PPV) of was 33% (95% CI: 6%, 76%). Noroozian et al [10] in a larger study of 515 women and 618 mastectomies with reconstruction, 485 of which were performed for cancer, found the cancer detection rate of screening mammography to be 1.5/1,000 screening mammograms, comparable to that for one native breast of age-matched women. However, Freyvogel et al [28] retrospectively evaluated 541 postmastectomy and autologous reconstruction patients. Of these, 397 patients had screening mammography and 537 patients underwent routine clinical examination. Of the patients in the cohort, 26 of 27 (96.3%) had a clinically detectable recurrence, and the two cancers detected on screening were also palpable on follow-up clinical examination. Lee et al [29] evaluated 554 mammograms (265 TRAM flap reconstructions); no cancers were detected through screening and no interval nonpalpable recurrent breast cancers missed at mammography were identified, yielding a 0% rate of detection (exact 95% CI: 0.0%, 1.4%). The authors concluded that screening this population is less effective than screening average-risk women in their 40s, although it should be noted that the upper end of the CI is in line with the rates reported by the other studies mentioned above. Of note, there are no studies specifically evaluating decrease in mortality from screening women in this setting. MRI Breast Without IV Contrast There is no relevant literature to support the use of MRI of the breast without IV contrast for screening in this clinical setting. MRI Breast Without and With IV Contrast There is insufficient evidence to support the use of MRI without and with IV contrast for screening in this setting. Based on breast cancer risk, including factors such as age at cancer diagnosis, breast density, and family history, women with a personal history of cancer may undergo MRI for the contralateral native breast [17]. In this setting, MRI will also allow for evaluation of the reconstructed breast and may be able to demonstrate recurrent malignancy, although the literature is scant with only several small studies and case reports [30,31]. Reiber et al [31], for example, used MRI to evaluate 41 patients with flap reconstructions, finding one mammographically and sonographically occult cancer in a patient with a latissimus dorsi flap. However, MRI also generated three false- positive . Sestamibi MBI There is no relevant literature to support the use of Tc-99m sestamibi MBI for screening in this clinical setting. US Breast There is no relevant literature to support the use of US for screening in this clinical setting. Variant 3: Female. Breast cancer screening. History of cancer, nonautologous (implant) reconstruction side(s). Please note that this clinical scenario is focused on the appropriateness of imaging modalities for screening the side of the mastectomy following reconstruction. For screening of the native breast in the setting of unilateral mastectomy, see the ACR Appropriateness Criteria® topic on “Breast Cancer Screening” [15]. For evaluation of the implant itself, discussion of the evidence regarding screening for implant rupture, and evaluation for

ACR Appropriateness Criteria® 6 Imaging after Mastectomy and Breast Reconstruction associated anaplastic large cell lymphoma, please see the ACR Appropriateness Criteria® topic on “Breast Implant Evaluation” [32]. Digital Breast Tomosynthesis Screening There is no relevant literature to support the use of DBT for screening in this clinical setting. Mammography Screening There is no relevant literature to support the use of mammography for screening in this clinical setting. FDG-PET Breast Dedicated There is no relevant literature to support the use of FDG-PET breast for screening in this clinical setting. MRI Breast Without IV Contrast There is no relevant literature to support the use of MRI without IV contrast for screening in this clinical setting. MRI Breast Without and With IV Contrast There is insufficient evidence to support screening women specifically to evaluate the postmastectomy breast with implant reconstruction. A small retrospective study of 45 breast MRI surveillance examinations performed in women who underwent mastectomy for either cancer or prophylaxis and had either implant, flap, or mixed reconstruction found no locoregional recurrences that were not also clinically suspected [33]. Golan et al [34] evaluated 159 women status post bilateral mastectomy and reconstruction who underwent 415 surveillance MRI examinations. In this study, the majority of the women (90%) had implant reconstruction. Of these, 405 (98%; 95% CI: 96%–99%) of the studies were negative, and one breast recurrence was found on MRI (cancer detection rate 2.4 per 1,000 MRI examinations, 95% CI: 0.4–13) in a woman who was also found to have metastatic disease. In addition, the false-positive rate was 90% (95% CI: 54%–99%). The interval cancer rate in this group was 5/1000 (95% CI: 1.3–17), and 4 women were diagnosed with metastatic disease. However, based on breast cancer risk, including factors such as age at cancer diagnosis, breast density, and family history, women with a personal history of cancer may undergo MRI for the contralateral native breast [17]. Sestamibi MBI There is no relevant literature to support the use of Tc-99m sestamibi MBI for screening in this clinical setting. US Breast There is no relevant literature to support the use of US for screening in this clinical setting. Variant 4: Female. Breast cancer screening. High-risk, bilateral prophylactic mastectomy, no reconstruction. See the ACR Appropriateness Criteria® topic on “Breast Cancer Screening” [15]. FDG-PET Breast Dedicated There is no relevant literature to support the use of FDG-PET breast for screening in this clinical setting. Digital Breast Tomosynthesis Screening There is no relevant literature to support the use of DBT for screening in this clinical setting. Mammography Screening There is no relevant literature to support the use of mammography for screening in this clinical setting. MRI Breast Without IV Contrast There is no relevant literature to support the use of MRI without IV contrast for screening in this clinical setting. MRI Breast Without and With IV Contrast There is insufficient evidence to support the use of MRI without and with IV contrast for breast cancer screening in this setting. Sestamibi MBI There is no relevant literature to support the use of Tc-99m sestamibi MBI for screening in this clinical setting. US Breast There is no relevant literature to support the use of US for screening in this clinical setting.

ACR Appropriateness Criteria® 7 Imaging after Mastectomy and Breast Reconstruction Variant 5: Female. Breast cancer screening. High-risk, bilateral prophylactic mastectomy with autologous reconstructions. See the ACR Appropriateness Criteria® topic on “Breast Cancer Screening” [15]. Digital Breast Tomosynthesis Screening There is no relevant literature to support the use of DBT for screening in this clinical setting. Mammography Screening There is insufficient evidence to support the use of mammography for breast cancer screening in this population. A recent study by Noroozian et al [10] found no evidence to support the use of screening mammography in women who had undergone bilateral prophylactic mastectomy with autologous reconstruction. Of 133 prophylactic mastectomies with autologous reconstruction (805 mammograms), the cancer detection rate with mammography was 0%. FDG-PET Breast Dedicated There is no relevant literature to support the use of FDG-PET breast for screening in this clinical setting. MRI Breast Without IV Contrast There is no relevant literature to support the use of MRI without IV contrast for screening in this clinical setting. MRI Breast Without and With IV Contrast Although there may be residual breast glandular tissue after mastectomy and MRI may be useful in delineating the amount of this residual tissue in women after prophylactic mastectomy [35], there is insufficient evidence to support the use of MRI breast without and with IV contrast for breast cancer screening in this population. A small retrospective study of breast MRI surveillance examinations performed in a subset of women who underwent bilateral mastectomy for either cancer or prophylaxis and had either implant, flap, or mixed reconstructions found no cancers that were not also evident on clinical examinations [33]. Sestamibi MBI There is no relevant literature to support the use of Tc-99m sestamibi MBI for screening in this clinical setting. US Breast There is no relevant literature to support the use of US for screening in this clinical setting. Variant 6: Female. Breast cancer screening. High-risk, bilateral prophylactic mastectomy with nonautologous (implant) reconstructions. Please note that this clinical scenario focuses on breast cancer screening for malignancy, see the ACR Appropriateness Criteria® topic on “Breast Cancer Screening” [15]. For evaluation of the implant itself and for discussion of the evidence regarding evaluation of saline or silicone implants in asymptomatic patients, please see the ACR Appropriateness Criteria® topic on “Breast Implant Evaluation” [32]. Digital Breast Tomosynthesis Screening There is no relevant literature to support the use of DBT for screening in this clinical setting. Mammography Screening There is no relevant literature to support the use of mammography for screening in this clinical setting. FDG-PET Breast Dedicated There is no relevant literature to support the use of FDG-PET breast for screening in this clinical setting. MRI Breast Without IV Contrast There is no relevant literature to support the use of MRI without IV contrast for screening in this clinical setting. MRI Breast Without and With IV Contrast There is insufficient evidence to support screening for women with prophylactic mastectomy and implant reconstruction. It has been suggested that the yield of screening in this setting is especially low in the setting of retropectoral implant placement, in which recurrences are most likely to be clinically palpable [33,34]. A small retrospective study of breast MRI in 48 women status post bilateral mastectomy with and without reconstruction, some of whom underwent surveillance MRI, found no malignancy that was not also evident on clinical examination [33]. A retrospective study of 159 women status post bilateral mastectomy and reconstruction and undergoing MRI surveillance found no cancers in the subset of 31 women who had mastectomy performed for risk reduction [34].

ACR Appropriateness Criteria® 8 Imaging after Mastectomy and Breast Reconstruction Sestamibi MBI There is no relevant literature to support the use of Tc-99m sestamibi MBI for screening in this clinical setting. US Breast There is no relevant literature to support the use of US for screening in this clinical setting. Variant 7: Female. Palpable lump or clinically significant pain on the side of the mastectomy without reconstruction. Initial imaging. Digital Breast Tomosynthesis Diagnostic There is insufficient evidence to support the use of DBT as the initial imaging modality in women with palpable lumps or clinically significant pain on the side of the mastectomy. However, DBT can be useful in the diagnostic setting. It is known to improve lesion characterization in noncalcified lesions and to improve cancer detection when compared to conventional mammographic workup [36-38]. Mammography Diagnostic There is limited evidence to support the use of diagnostic mammography as the initial imaging modality in this clinical setting. A study of 67 women who underwent mastectomy and were suspected of recurrence found 3/61 cancers detected only on mammography and not on US [16]. Another study evaluating palpable lumps in 101 patients who had undergone mastectomy, the majority of whom (69%) had reconstruction with implants, demonstrated that mammography could be useful to confirm benign findings such as fat necrosis and benign calcifications identified on US [39]. However, diagnostic mammography yielded no additional cancers beyond those depicted on US. FDG-PET Breast Dedicated There is no relevant literature to support the use of FDG-PET breast in this clinical setting. MRI Breast Without IV Contrast There is no relevant literature to support the use of MRI without IV contrast in this clinical setting. MRI Breast Without and With IV Contrast There is no evidence to support the use of MRI breast without and with IV contrast as the initial imaging modality in women with palpable lump or clinically significant pain on the mastectomy side. However, MRI may help characterize malignancy once identified and has been found to be more accurate than US in delineating extent of disease, although there is a paucity of evidence-based literature [18]. Sestamibi MBI There are a few small retrospective studies evaluating the use of Tc-99m sestamibi MBI in the context of a clinically suspicious lump. For example, Usmani et al [40] looked at 41 consecutive postmastectomy patients and found a sensitivity of 89%, specificity of 92%, PPV of 96%, negative predictive value (NPV) of 80%, and accuracy of 90% with Tc-99m sestamibi MBI. This was compared to US, which had a lower sensitivity of 86%, specificity of 77%, PPV of 89%, NPV of 71%, and accuracy of 83% (P = .001). The authors found that the combined sensitivity was 100%, specificity 77%, PPV 90%, NPV 100%, and accuracy 93%. However, there is insufficient evidence to support the use of Tc-99m sestamibi MBI as the initial imaging modality in this setting. US Breast A retrospective evaluation of 118 palpable lumps in 101 patients, 9% of whom were status postmastectomy found 13 cancers in the mastectomy bed in women with a history of cancer. US had a high NPV of 97% and a PPV of 27% [39]. Gweon et al [41] evaluated both palpable and nonpalpable US BI-RADS categorization of lesions 4a and above at the mastectomy site and found 9/20 (45%) malignancies among palpable lesions; they also found that 100% of all BI-RADS 4c and BI-RADS 5 lesions proved to be malignant. In the event of an indeterminate US finding or an US finding suggestive of fat necrosis, diagnostic mammography or DBT may be helpful for lesion characterization and may preclude the need for biopsy if a clearly benign finding such as an oil cyst is identified. Variant 8: Female. Palpable lump or clinically significant pain on the side of the mastectomy with reconstruction (autologous or nonautologous). Initial imaging. Please note that this clinical scenario focuses on evaluation of the reconstruction, which may be an implant reconstruction. For imaging evaluation of the implant itself and for discussion of the evidence regarding evaluation of implant integrity, please see the ACR Appropriateness Criteria® topic on “Breast Implant Evaluation” [32].

ACR Appropriateness Criteria® 9 Imaging after Mastectomy and Breast Reconstruction Digital Breast Tomosynthesis Diagnostic There is insufficient evidence to support the use of DBT as the initial imaging modality for women with palpable lumps or clinically significant pain on the side of the mastectomy with reconstruction. However, DBT can be useful in the diagnostic setting. It is known to improve lesion characterization in noncalcified lesions and to improve cancer detection when compared to conventional mammographic workup [36-38]. Mammography Diagnostic There is limited evidence to support the use of diagnostic mammography as the initial imaging modality in this clinical setting. Mammography may be helpful in identifying a benign postsurgical etiology of a palpable concern such as fat necrosis or oil cyst. For example, a study evaluating palpable lumps in 101 patients who had undergone mastectomy, the majority of whom (69%) had reconstruction with implants, demonstrated that mammography could be useful to confirm benign findings such as fat necrosis and benign calcifications identified on US [39]. However, the study also showed that diagnostic mammography yielded no additional cancers beyond those depicted on US. In another small study, Edeiken et al [42] found that mammography depicted only 14 of 25 (56%) of the recurrences visualized on US in women who had undergone autogenous myocutaneous flaps after mastectomy. FDG-PET Breast Dedicated There is no relevant literature to support the use of FDG-PET breast as the initial imaging modality in this clinical setting. MRI Breast Without IV Contrast There is no role for MRI without IV contrast as the initial imaging modality in this clinical setting. For evaluation of implant integrity, please see the ACR Appropriateness Criteria® topic on “Breast Implant Evaluation” [32]. MRI Breast Without and With IV Contrast There is insufficient evidence for MRI without and with IV contrast as the initial imaging modality in this setting. There are a few small studies evaluating MRI in women with symptomatic concerns and breast reconstruction. Devon et al [43] evaluated 24 TRAM reconstructions in 22 women with the majority of cases (64%) presenting with palpable abnormality or pain. Sixteen women in the study had MRI without mammography or US. In 4 of 24 cases (17%), MRI detected recurrent breast cancer, including axillary nodal recurrence. Of note, tissue expanders may be a contraindication to breast MRI [44]. Sestamibi MBI There is no relevant literature to support the use of Tc-99m sestamibi MBI as the initial imaging modality in this clinical setting. US Breast There are a few small studies to support the use of US this setting. Dashevsky et al [39] looked at 118 palpable lumps in 101 patients postmastectomy (85% of whom were also postreconstruction). In total, 14 palpable lumps in 12 patients were malignant, and 104 palpable lumps in 89 patients were nonmalignant. Thirteen cancers were identified on US with only two false-positives (NPV 97%, PPV 27%). Edeiken et al [42] evaluated 20 women with autologous flap reconstruction after mastectomy who presented with palpable lumps; US ultimately identified 39 of 39 (100%) of cancers, 18 of which were palpable and 21 of which were occult. In the event of an indeterminate US finding, or an US finding suggestive of fat necrosis, diagnostic mammography or DBT may be helpful for lesion characterization and may preclude the need for biopsy if a clearly benign finding such as an oil cyst is identified. Summary of Recommendations • Variant 1: Imaging for breast cancer screening is usually not appropriate for a female with history of cancer and no reconstruction on breast(s) that underwent mastectomy. • Variant 2: Mammography or DBT for breast cancer screening may be appropriate for a female with history of cancer and autologous reconstruction on breast(s) with or without implant(s). • Variant 3: Imaging for breast cancer screening is usually not appropriate for a female with history of cancer and nonautologous (implant) reconstruction on breast(s). • Variant 4: Imaging for breast cancer screening is usually not appropriate for a high-risk female with no reconstruction on that underwent bilateral prophylactic mastectomy.

ACR Appropriateness Criteria® 10 Imaging after Mastectomy and Breast Reconstruction • Variant 5: Imaging for breast cancer screening is usually not appropriate for a high-risk female with autologous reconstructions on breasts that underwent bilateral prophylactic mastectomy. • Variant 6: Imaging for breast cancer screening is usually not appropriate for a high-risk female with nonautologous (implant) reconstructions on breasts that underwent a bilateral prophylactic mastectomy. • Variant 7: US breast as initial imaging is usually appropriate for a female with a palpable lump or clinically significant pain on the side of the mastectomy without reconstruction. • Variant 8: US breast as initial imaging is usually appropriate for a female with a palpable lump or clinically significant pain on the side of the mastectomy with reconstruction (autologous or nonautologous). Supporting Documents The evidence table, literature search, and appendix for this topic are available at https://acsearch.acr.org/list. The appendix includes the strength of evidence assessment and the final rating round tabulations for each recommendation. For additional information on the Appropriateness Criteria methodology and other supporting documents go to www.acr.org/ac. Appropriateness Category Names and Definitions Appropriateness Appropriateness Category Name Appropriateness Category Definition Rating The imaging procedure or treatment is indicated in the Usually Appropriate 7, 8, or 9 specified clinical scenarios at a favorable risk-benefit ratio for patients. The imaging procedure or treatment may be indicated in the specified clinical scenarios as an alternative to May Be Appropriate 4, 5, or 6 imaging procedures or treatments with a more favorable risk-benefit ratio, or the risk-benefit ratio for patients is equivocal. The individual ratings are too dispersed from the panel median. The different label provides transparency May Be Appropriate 5 regarding the panel’s recommendation. “May be (Disagreement) appropriate” is the rating category and a rating of 5 is assigned. The imaging procedure or treatment is unlikely to be indicated in the specified clinical scenarios, or the Usually Not Appropriate 1, 2, or 3 risk-benefit ratio for patients is likely to be unfavorable.

Relative Radiation Level Information Potential adverse health effects associated with radiation exposure are an important factor to consider when selecting the appropriate imaging procedure. Because there is a wide range of radiation exposures associated with different diagnostic procedures, a relative radiation level (RRL) indication has been included for each imaging examination. The RRLs are based on effective dose, which is a radiation dose quantity that is used to estimate population total radiation risk associated with an imaging procedure. Patients in the pediatric age group are at inherently higher risk from exposure, because of both organ sensitivity and longer life expectancy (relevant to the long latency that appears to accompany radiation exposure). For these reasons, the RRL dose estimate ranges for pediatric examinations are lower as compared with those specified for adults (see Table below). Additional information regarding radiation dose assessment for imaging examinations can be found in the ACR Appropriateness Criteria® Radiation Dose Assessment Introduction document [45].

ACR Appropriateness Criteria® 11 Imaging after Mastectomy and Breast Reconstruction Relative Radiation Level Designations Adult Effective Dose Estimate Pediatric Effective Dose Estimate Relative Radiation Level* Range Range 0 mSv 0 mSv O <0.1 mSv <0.03 mSv ☢ 0.1-1 mSv 0.03-0.3 mSv ☢☢ 1-10 mSv 0.3-3 mSv ☢☢☢ 10-30 mSv 3-10 mSv ☢☢☢☢ 30-100 mSv 10-30 mSv ☢☢☢☢☢ *RRL assignments for some of the examinations cannot be made, because the actual patient doses in these procedures vary as a function of a number of factors (eg, region of the body exposed to ionizing radiation, the imaging guidance that is used). The RRLs for these examinations are designated as “Varies.” References 1. Green LA, Karow JA, Toman JE, Lostumbo A, Xie K. Review of and reconstruction for the radiologist with emphasis on MRI. Clin Imaging 2018;47:101-17. 2. Kummerow KL, Du L, Penson DF, Shyr Y, Hooks MA. Nationwide trends in mastectomy for early-stage breast cancer. JAMA Surg 2015;150:9-16. 3. Panchal H, Pilewskie ML, Sheckter CC, et al. National trends in contralateral prophylactic mastectomy in women with locally advanced breast cancer. J Surg Oncol 2019;119:79-87. 4. Zakhireh J, Fowble B, Esserman LJ. Application of screening principles to the reconstructed breast. J Clin Oncol 2010;28:173-80. 5. Medina-Franco H, Vasconez LO, Fix RJ, et al. Factors associated with local recurrence after skin-sparing mastectomy and immediate breast reconstruction for invasive breast cancer. Ann Surg 2002;235:814-9. 6. Kaoutzanis C, Xin M, Ballard TN, et al. Autologous Fat Grafting After Breast Reconstruction in Postmastectomy Patients: Complications, Biopsy Rates, and Locoregional Cancer Recurrence Rates. Ann Plast Surg 2016;76:270-5. 7. Adrada BE, Whitman GJ, Crosby MA, Carkaci S, Dryden MJ, Dogan BE. Multimodality Imaging of the Reconstructed Breast. Curr Probl Diagn Radiol 2015;44:487-95. 8. Fajardo LL, Roberts CC, Hunt KR. Mammographic surveillance of breast cancer patients: should the mastectomy site be imaged? AJR Am J Roentgenol 1993;161:953-5. 9. McCarthy CM, Pusic AL, Sclafani L, et al. Breast cancer recurrence following prosthetic, postmastectomy reconstruction: incidence, detection, and treatment. Plast Reconstr Surg 2008;121:381-8. 10. Noroozian M, Carlson LW, Savage JL, et al. Use of Screening Mammography to Detect Occult Malignancy in Autologous Breast Reconstructions: A 15-year Experience. Radiology 2018;289:39-48. 11. Patterson SG, Teller P, Iyengar R, et al. Locoregional recurrence after mastectomy with immediate transverse rectus abdominis myocutaneous (TRAM) flap reconstruction. Ann Surg Oncol 2012;19:2679-84. 12. Romics L, Jr., Chew BK, Weiler-Mithoff E, et al. Ten-year follow-up of skin-sparing mastectomy followed by immediate breast reconstruction. Br J Surg 2012;99:799-806. 13. Warren Peled A, Foster RD, Stover AC, et al. Outcomes after total skin-sparing mastectomy and immediate reconstruction in 657 breasts. Ann Surg Oncol 2012;19:3402-9. 14. Hedegard W, Niell B, Specht M, Winograd J, Rafferty E. Breast reconstruction with a deep inferior epigastric perforator flap: imaging appearances of the normal flap and common complications. AJR Am J Roentgenol 2013;200:W75-84. 15. Mainiero MB, Moy L, Baron P, et al. ACR Appropriateness Criteria® Breast Cancer Screening. J Am Coll Radiol 2017;14:S383-S90. 16. Rissanen TJ, Makarainen HP, Mattila SI, Lindholm EL, Heikkinen MI, Kiviniemi HO. Breast cancer recurrence after mastectomy: diagnosis with mammography and US. Radiology 1993;188:463-7. 17. Monticciolo DL, Newell MS, Moy L, Niell B, Monsees B, Sickles EA. Breast Cancer Screening in Women at Higher-Than-Average Risk: Recommendations From the ACR. J Am Coll Radiol 2018;15:408-14. 18. Yilmaz MH, Esen G, Ayarcan Y, et al. The role of US and MR imaging in detecting local chest wall tumor recurrence after mastectomy. Diagn Interv Radiol 2007;13:13-8.

ACR Appropriateness Criteria® 12 Imaging after Mastectomy and Breast Reconstruction 19. Kim HJ, Kwak JY, Choi JW, et al. Impact of US surveillance on detection of clinically occult locoregional recurrence after mastectomy for breast cancer. Ann Surg Oncol 2010;17:2670-6. 20. Lee JH, Kim EK, Oh JY, et al. US screening for detection of nonpalpable locoregional recurrence after mastectomy. Eur J Radiol 2013;82:485-9. 21. Greenberg JS, Javitt MC, Katzen J, Michael S, Holland AE. Clinical performance metrics of 3D digital breast tomosynthesis compared with 2D digital mammography for breast cancer screening in community practice. AJR Am J Roentgenol 2014;203:687-93. 22. Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA 2014;311:2499-507. 23. Caumo F, Bernardi D, Ciatto S, et al. Incremental effect from integrating 3D-mammography (tomosynthesis) with 2D-mammography: Increased breast cancer detection evident for screening centres in a population-based trial. Breast 2014;23:76-80. 24. Bernardi D, Ciatto S, Pellegrini M, et al. Application of breast tomosynthesis in screening: incremental effect on mammography acquisition and reading time. Br J Radiol 2012;85:e1174-8. 25. Bernardi D, Caumo F, Macaskill P, et al. Effect of integrating 3D-mammography (digital breast tomosynthesis) with 2D-mammography on radiologists' true-positive and false-positive detection in a population breast screening trial. Eur J Cancer 2014;50:1232-8. 26. Ciatto S, Houssami N, Bernardi D, et al. Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. Lancet Oncol 2013;14:583-9. 27. Helvie MA, Bailey JE, Roubidoux MA, et al. Mammographic screening of TRAM flap breast reconstructions for detection of nonpalpable recurrent cancer. Radiology 2002;224:211-6. 28. Freyvogel M, Padia S, Larson K, et al. Screening mammography following autologous breast reconstruction: an unnecessary effort. Ann Surg Oncol 2014;21:3256-60. 29. Lee JM, Georgian-Smith D, Gazelle GS, et al. Detecting nonpalpable recurrent breast cancer: the role of routine mammographic screening of transverse rectus abdominis myocutaneous flap reconstructions. Radiology 2008;248:398-405. 30. Al-Khalili R, Wynn RT, Ha R. The Contact Zone: A Common Site of Tumor Recurrence in a Patient Who Underwent Skin-Sparing Mastectomy and Myocutaneous Flap Reconstruction. Curr Probl Diagn Radiol 2016;45:233-4. 31. Rieber A, Schramm K, Helms G, et al. Breast-conserving surgery and autogenous tissue reconstruction in patients with breast cancer: efficacy of MRI of the breast in the detection of recurrent disease. Eur Radiol 2003;13:780-7. 32. Lourenco AP, Moy L, Baron P, et al. ACR Appropriateness Criteria® Breast Implant Evaluation. J Am Coll Radiol 2018;15:S13-S25. 33. Vanderwalde LH, Dang CM, Tabrizi R, Saouaf R, Phillips EH. Breast MRI after bilateral mastectomy: is it indicated? Am Surg 2011;77:180-4. 34. Golan O, Amitai Y, Barnea Y, Menes TS. Yield of surveillance magnetic resonance imaging after bilateral mastectomy and reconstruction: a retrospective cohort study. Breast Cancer Res Treat 2019;174:463-68. 35. Grinstein O, Krug B, Hellmic M, et al. Residual glandular tissue (RGT) in BRCA1/2 germline mutation carriers with unilateral and bilateral prophylactic mastectomies. Surg Oncol 2019;29:126-33. 36. Gennaro G, Hendrick RE, Toledano A, et al. Combination of one-view digital breast tomosynthesis with one- view digital mammography versus standard two-view digital mammography: per lesion analysis. Eur Radiol 2013;23:2087-94. 37. Waldherr C, Cerny P, Altermatt HJ, et al. Value of one-view breast tomosynthesis versus two-view mammography in diagnostic workup of women with clinical signs and symptoms and in women recalled from screening. AJR Am J Roentgenol 2013;200:226-31. 38. Yang TL, Liang HL, Chou CP, Huang JS, Pan HB. The adjunctive digital breast tomosynthesis in diagnosis of breast cancer. Biomed Res Int 2013;2013:597253. 39. Dashevsky BZ, Hayward JH, Woodard GA, Joe BN, Lee AY. Utility and Outcomes of Imaging Evaluation for Palpable Lumps in the Postmastectomy Patient. AJR Am J Roentgenol 2019;213:464-72. 40. Usmani S, Khan H, Ahmed N, Marafi F, Garvie N. in conjunction with ultrasonography for local breast cancer recurrence in post-mastectomy breast. Br J Radiol 2010;83:934-9. 41. Gweon HM, Son EJ, Youk JH, Kim JA, Chung J. Value of the US BI-RADS final assessment following mastectomy: BI-RADS 4 and 5 lesions. Acta Radiol 2012;53:255-60.

ACR Appropriateness Criteria® 13 Imaging after Mastectomy and Breast Reconstruction 42. Edeiken BS, Fornage BD, Bedi DG, Sneige N, Parulekar SG, Pleasure J. Recurrence in autogenous myocutaneous flap reconstruction after mastectomy for primary breast cancer: US diagnosis. Radiology 2003;227:542-8. 43. Devon RK, Rosen MA, Mies C, Orel SG. Breast reconstruction with a transverse rectus abdominis myocutaneous flap: spectrum of normal and abnormal MR imaging findings. Radiographics 2004;24:1287-99. 44. Shellock FG. Reference Manual for Magnetic Resonance Safety, Implants, and Devices: 2019 Edition. Los Angeles, CA: Biomedical Research Publishing Group; 2019. 45. American College of Radiology. ACR Appropriateness Criteria® Radiation Dose Assessment Introduction. Available at: https://www.acr.org/-/media/ACR/Files/Appropriateness- Criteria/RadiationDoseAssessmentIntro.pdf. Accessed March 27, 2020.

The ACR Committee on Appropriateness Criteria and its expert panels have developed criteria for determining appropriate imaging examinations for diagnosis and treatment of specified medical condition(s). These criteria are intended to guide radiologists, radiation oncologists and referring physicians in making decisions regarding radiologic imaging and treatment. Generally, the complexity and severity of a patient’s clinical condition should dictate the selection of appropriate imaging procedures or treatments. Only those examinations generally used for evaluation of the patient’s condition are ranked. Other imaging studies necessary to evaluate other co-existent diseases or other medical consequences of this condition are not considered in this document. The availability of equipment or personnel may influence the selection of appropriate imaging procedures or treatments. Imaging techniques classified as investigational by the FDA have not been considered in developing these criteria; however, study of new equipment and applications should be encouraged. The ultimate decision regarding the appropriateness of any specific radiologic examination or treatment must be made by the referring physician and radiologist in light of all the circumstances presented in an individual examination.

ACR Appropriateness Criteria® 14 Imaging after Mastectomy and Breast Reconstruction